Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view

Clinical Rheumatology

Volumn 34, Issue 4, 2015, Pages 635-640

  Pineda, Carlos ^a   Caballero Uribe, Carlo V ^b   de Oliveira, Marcia Gonclaves ^c   Lipszyc, Pedro Saul ^d   Lopez, Jose Julian ^e   Mataos Moreira, Marcelo Mario ^c   Azevedo, Valderilio Feijo ^f  

^a INSTITUTO NACIONAL DE REHABILITACIÓN   (Mexico)

^b UNIVERSIDAD DEL NORTE   (Colombia)

^c Agencia Nacional de Vigilancia Sanitaria Brazil   (Brazil)

^d UNIVERSIDAD DE BUENOS AIRES   (Argentina)

^e UNIVERSIDAD NACIONAL DE COLOMBIA   (Colombia)

^f FEDERAL UNIVERSITY OF PARANÁ   (Brazil)

Author keywords

Biosimilars; Naming; Pharmacovigilance; Surveillance; Traceability

Indexed keywords

BIOSIMILAR AGENT; BIOLOGICAL PRODUCT;

ARTICLE; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; PRIORITY JOURNAL; SOUTH AND CENTRAL AMERICA; CHEMISTRY; PATIENT SAFETY; PHARMACEUTICS; PRACTICE GUIDELINE; PROCEDURES; STANDARDS; THERAPEUTIC EQUIVALENCE;

BIOLOGICAL PRODUCTS; BIOSIMILAR PHARMACEUTICALS; HUMANS; LATIN AMERICA; PATIENT SAFETY; PHARMACOVIGILANCE; PRACTICE GUIDELINES AS TOPIC; TECHNOLOGY, PHARMACEUTICAL; THERAPEUTIC EQUIVALENCY;

EID: 84925494785     PISSN: 07703198     EISSN: 14349949     Source Type: Journal    
DOI: 10.1007/s10067-015-2887-0     Document Type: Article

References (19)

1. Azevedo VF, Mysler E, Álvarez AA, Hughes J, Flores-Murrieta FJ, Ruiz de Castilla EM (2014) Recommendations for the regulation of biosimilars and their implementation in Latin America. GaBI J 3(3):143–148
2. Knezevic I, Griffiths E (2011) Biosimilars—global issues, national solutions. Biologicals 39:252–255
3. Dolinar RO, Reilly MS (2013) The future of biological therapy: a pathway forward for biosimilars. GaBI J 2(1):36–40
4. Azevedo VF, Sandorff E, Siemak B, Halbert RJ (2012) Potential regulatory and commercial environment for biosimilars in Latin America. Value Heal Reg Issues 1:228–234
5. Committee for Medicinal Products for Human Use (CHMP) (2006) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. European Medical Agency. EMEA/CHMP/BMWP/42832/2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf. Accessed 15 Oct 2014
6. World Health Organization (2002) Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for drug regulatory authorities. World Health Organization. WHO/DMP/RGS/98.5. http://apps.who.int/prequal/info_general/documents/WHO_DMP_RGS_98_5_R.pdf. Accessed 15 Oct 2014
7. Giezen TJ, Straus SMJM (2012) Pharmacovigilance of biosimilars: challenges and possible solutions. GaBI J 1(3–4):118–119
8. Silverman E (2014) Biosimilars: what’s in a name? BMJ 348:g272
9. World Health Organization (2013) Executive Summary. 55th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Geneva, 16-18 October 2012. INN Working Doc. 13.329. World Health Organization. www.who.int/medicines/services/inn/55th_Executive_Summary.pdf. Accessed 15 Oct 2014
10. Casadevall N, Edwards IR, Felix T, Graze PF, Litten JB, Strober BE, Warnock DG (2013) Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther 13(7):1039–1047
11. Vermeer NS, Straus SM, Mantel-Teeuwisse AK, Domergue F, Egberts TC, Leufkens HG, De Bruin ML (2013) Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Report System (FAERS) and EudraVigilance databases. Drug Saf 36(8):617–625
12. Dörner T, Strand V, Castañeda-Hernández G, Ferraccioli G, Isaacs JD, Kvien TK, Martin-Mola E, Mittendorf T, Smolen JS, Burmester GR (2013) The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 72:322–328
13. Desanvicente-Celis Z, Caro-Moreno J, Enciso-Zuluaga M, Anaya JM (2013) Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases. Biosimilars 3:1–17
14. Scheinberg M, Castañeda-Hernández G (2014) Anti-tumor necrosis factor patent expiration and the risks of biocopies in clinical practice. Arthritis Res Ther 16:501
15. Saavedra I, Quinones L (2006) Considerations about the approval of biosimilar formulations (biogenerics) in Chile. [Interchangeability of biological drugs: considerations about the approval of biogeneric formulations in Chile]. Rev Méd Chile 134:1583–1588
16. Chiann C, de Souza Teixeira L, Fernandes de Santana F, Cardoso S, da Costa César I, Pianetti GA (2013) Biosimilarity in Latin America. GaBI J 2(2):94–96
17. Calvo B, Zúñiga L (2011) Risk Management Plan and Pharmacovigilance System—biopharmaceuticals: biosimilars. In: Nota G (ed) Risk Management Trends. InTech, Rijeka
18. Official Journal of the European Union (2010) Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal L 348/74. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF
19. Mysler E, Scheinberg M (2012) Biosimilars in rheumatology: a view from Latin America. Clin Rheumatol 31:1279–1280